Sterility sampling test method and apparatus

Abstract

In a work isolator which is a work chamber maintained in a sterile condition, a predetermined sample containers to be subjected to a sterile test are extracted by a rejection device from containers filled with a material and sealed by a filling and sealing line, and a robot places the extracted sample containers on a collection pallet. The sample containers are moved from the work isolator to an accommodation device together with the pallet. The accommodation device is separated from the work isolator while being maintained in a sterile condition and is then connected to a test isolator which is a testing chamber maintained in a sterile condition. The sample containers are moved from the accommodation device into the test isolator while being maintained in a sterile condition. The sample containers are maintained in the sterile condition at all times from the work chamber to the testing chamber. Therefore, the need for sterilization of the outer surfaces of the sample containers at the time of sterility test in the testing chamber is eliminated and the drug sterility test can be immediately started.

1 . A sterility sampling test method in which a work chamber the interior of which is maintained in a sterile condition, sealing means of sealing containers in the work chamber and a testing chamber which is installed at a distance from the work chamber and the interior of which is maintained in a sterile condition are provided, and containers sealed by the sealing means in the work chamber are transported to the testing chamber to be subjected to a sterility test in the testing chamber, said method comprising: 
 a step of providing accommodation means capable of being connected to and being disconnected from each of the work chamber and the testing chamber while being maintained in a sterile condition, and holding a predetermined number of sample containers in the sealed containers without conveying the sample containers out of the work chamber;    a step of connecting the accommodation means to the work chamber;    a step of moving the sample containers in the work chamber into the accommodation means;    a step of disconnecting from the work chamber the accommodation means in which the sample containers are accommodated;    a step of connecting the accommodation means to the testing chamber;    a step of moving the sample containers in the accommodation means into the testing chamber; and    a step of testing sterility of a material filling each sample container by opening the sample container in the testing chamber.    
     
     
         2 . A sterility sampling test apparatus having a work chamber the interior of which is maintained in a sterile condition, sealing means of sealing containers in the work chamber, and a testing chamber which is installed at a distance from the work chamber and the interior of which is maintained in a sterile condition, containers sealed by the sealing means in the work chamber being transported to the testing chamber to be subjected to a sterility test in the testing chamber, said apparatus comprising: 
 accommodation means capable of being connected to and being disconnected from each of the work chamber and the testing chamber while being maintained in a sterile condition; and    transport means provided in the work chamber, the transport means accommodating in said accommodation means the containers sealed by the sealing means, while said accommodation means is being maintained in the state of being connected to the work chamber.    
     
     
         3 . A sterility sampling test apparatus according to  claim 2 , wherein the work chamber has an inlet through which containers are conveyed from the outside into the work chamber while being maintained in a sterile condition, filling means of filling the containers with a material, and an outlet through which the containers filled with the material by said filling means and sealed by the sealing means are conveyed to the outside while being maintained in a sterile condition, and said transport means includes rejection means of moving a plurality of number of sample containers in the containers sealed by the sealing means to an extraction position set in the work chamber, and moving and placing means of enabling the sample containers at the extraction position to be accommodated in the accommodation means.